- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01426633
Combination Therapy of Gemcitabine and Trabectedin in L-sarcomas
December 15, 2014 updated by: Bernd Kasper, Heidelberg University
Phase I Dose Escalating Trial Evaluating the Combination of Gemcitabine and Trabectedin in Patients With Advanced and/or Metastatic Leiomyosarcoma or Liposarcoma
L-sarcomas represent about one third of all adult soft tissue sarcomas (24 % liposarcomas and 12 % leiomyosarcomas).
Approval for the induction of trabectedin into the treatment armamentarium of advanced and/or metastatic soft tissue sarcomas after treatment failure with anthracyclines and/or ifosfamide depended mainly on its activity in the L-sarcomas (Garcia-Carbonero 2004, Le Cesne 2005, and Demetri 2009).
Significant activity has been described for the use of gemcitabine and especially the combination of gemcitabine and docetaxel mainly in leiomyosarcomas and liposarcomas (Maki 2007).
However, the combination of gemcitabine and docetaxel is associated with significant toxicity.
Pulmonary toxicity and refractory peripheral oedema are the most common severe adverse events.
The aim of the present phase I study will be to examine safety data of this promising treatment combination of gemcitabine and trabectedin in L-sarcomas.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mannheim, Germany, 68167
- Mannheim university medical center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with histologically confirmed L-sarcomas (leiomyosarcoma and liposarcoma)
- Measurable disease according to RECIST 1.1
- Any treatment line except adjuvant setting: evidence of primary metastatic situation or disease progression within the last 6 months (based on RECIST 1.1) in computed tomography or magnetic resonance imaging
- Any prior treatment possible
- Age >= 18 years
- WHO PS =< 1
- Effective contraception during study medication and up to 3 months from treatment discontinuation
- Signed informed consent form
Exclusion Criteria:
- Surgical intervention < 4 weeks
- Pregnancy or lactation
- Known allergic reaction to trabectedin or gemcitabine or one of their components
- The following laboratory values:
Absolute neutrophil count < 1.5 x 103/mm3 Platelets < 100.000/mm3 Hb < 9 g/dL Serum creatinine >= 2.5 mg/dl SGOT and/or SGPT and/or alkaline phosphatase and/or CPK > 2.5 x ULN Total bilirubin > 1 x ULN except in the case of Gilbert's syndrome
- Participation in another study (four weeks before and during the study)
- Prior malignancy apart from completely resected basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemcitabine + Trabectedin
|
Combination therapy of gemcitabine and trabectedin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the maximum tolerated dose (MTD) of the combination of gemcitabine and trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma and liposarcoma.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the recommended phase II dose (RPTD) of the combination of gemcitabine and trabectedin (Yondelis®) in patients with advanced and/or metastatic leiomyosarcoma and liposarcoma.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bernd Kasper, MD, PhD, University of Heidelberg, Mannheim University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 29, 2011
First Submitted That Met QC Criteria
August 30, 2011
First Posted (Estimate)
August 31, 2011
Study Record Updates
Last Update Posted (Estimate)
December 16, 2014
Last Update Submitted That Met QC Criteria
December 15, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Neoplasms, Muscle Tissue
- Neoplasms, Adipose Tissue
- Leiomyosarcoma
- Liposarcoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Gemcitabine
- Trabectedin
Other Study ID Numbers
- GISG-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leiomyosarcoma
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingLocally Advanced Leiomyosarcoma | Metastatic Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Leiomyosarcoma | Uterine Corpus LeiomyosarcomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Uterine Corpus LeiomyosarcomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Leiomyosarcoma | Stage IIIA Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IIIB Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IIIC Uterine Corpus Leiomyosarcoma... and other conditionsUnited States
-
National Cancer Institute (NCI)RecruitingLocally Advanced Uterine Corpus Leiomyosarcoma | Metastatic Uterine Corpus Leiomyosarcoma | Stage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Unresectable Uterine Corpus LeiomyosarcomaUnited States, Puerto Rico
-
Gustave Roussy, Cancer Campus, Grand ParisCompletedUterus Leiomyosarcoma | Soft Tissue LeiomyosarcomaFrance
-
National Cancer Institute (NCI)Active, not recruitingStage III Uterine Corpus Leiomyosarcoma AJCC v8 | Stage IV Uterine Corpus Leiomyosarcoma AJCC v8 | Uterine Corpus LeiomyosarcomaUnited States
-
Kristen GanjooRecruitingUterine Leiomyosarcoma | LMS - LeiomyosarcomaUnited States
-
Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); EMD SeronoTerminatedMetastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Metastatic Liposarcoma | Unresectable LiposarcomaUnited States
-
David Liebner, MDWithdrawnLocally Advanced Leiomyosarcoma | Metastatic Leiomyosarcoma | Unresectable Leiomyosarcoma | Stage III Retroperitoneal Sarcoma AJCC v8 | Stage IIIA Retroperitoneal Sarcoma AJCC v8 | Stage IIIB Retroperitoneal Sarcoma AJCC v8 | Stage IV Retroperitoneal Sarcoma AJCC v8United States
-
Gachon University Gil Medical CenterMerck KGaA, Darmstadt, Germany; Chong Kun Dang Pharmaceutical Corp.RecruitingLeiomyosarcoma MetastaticKorea, Republic of
Clinical Trials on Gemcitabine + Trabectedin
-
Italian Sarcoma GroupPharmaMarRecruitingSoft Tissue Sarcoma | Leiomyosarcoma of OvaryItaly
-
Mario Negri Institute for Pharmacological ResearchPharmaMarCompletedLeiomyosarcomaItaly
-
Italian Sarcoma GroupAstraZeneca; PharmaMarActive, not recruitingAdvanced Soft Tissue SarcomaItaly
-
Italian Sarcoma GroupPharmaMarWithdrawnLeiomyosarcoma | Liposarcoma | Synovial SarcomaItaly
-
Sarcoma Oncology Research Center, LLCRecruitingLeiomyosarcomaUnited States
-
PharmaMar, SpainCompletedSoft Tissue SarcomaGermany
-
Gynecologic Oncology GroupNational Cancer Institute (NCI)Completed
-
Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)CompletedSarcomaUnited States
-
European Organisation for Research and Treatment...CompletedSarcoma | Small Intestine Cancer | Ovarian Cancer | Brain and Central Nervous System Tumors | Endometrial Cancer | Gastrointestinal Stromal Tumor
-
European Organisation for Research and Treatment...CompletedUnspecified Adult Solid Tumor, Protocol SpecificFrance, Spain, Denmark, Netherlands, Norway, Belgium, United Kingdom, Israel, Italy, Switzerland, Germany, Austria, Greece, Portugal